K930507 is an FDA 510(k) clearance for the CUSTOM ORTHOPAEDIC TRAYS (PACKS). This device is classified as a Knife, Orthopedic (Class I - General Controls, product code HTS).
Submitted by Associated Medical Products Co. (St. Louis Park, US). The FDA issued a Cleared decision on February 22, 1994, 386 days after receiving the submission on February 1, 1993.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.
| 510(k) Number | K930507 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 1993 |
| Decision Date | February 22, 1994 |
| Days to Decision | 386 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | HTS — Knife, Orthopedic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4540 |